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A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryCBKM120F2202
2011-005932-24, NCT01572727

Trial Description

Summary

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

Eligibility Criteria

Inclusion Criteria:

  • Breast cancer that is locally advanced or metastatic
  • HER2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
  • A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
  • Adequate bone marrow and organ function
  • Measurable or non-measurable disease

Exclusion Criteria:

  • Prior chemotherapy for locally advanced or metastatic disease
  • Previous treatment with PI3K or AKT inhibitors
  • Symptomatic brain metastases
  • Concurrent malignancy or malignancy within 3 years prior to start of study treatment
  • Certain drugs or radiation within 2-4 weeks of enrollment
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease as defined in the protocol
  • Known hypersensitivity or contraindications to use paclitaxel
  • Pregnant or nursing (lactating) woman
  • Certain scores on an anxiety and depression mood questionaire given at screening
  • Other protocol defined criteria may apply

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis PharmaceuticalsStudy Director

Novartis PharmaceuticalsPh: 1-888-669-6682

Trial Sites

U.S.A.
Arizona
  Chandler
 Ironwood Cancer and Research Centers - Chandler
 Wendy Schwoegler
  Email: wschwoegler@ironwoodcrc.com
 Mikhail ShtivelbandPrincipal Investigator
  Phoenix
 Arizona Oncology Associates - Biltmore Cancer Center
 Taqi Mohammad Ph: 520-393-4468
  Email: taqi.mohammad@mckesson.com
 Leona DowneyPrincipal Investigator
Arkansas
  Fayetteville
 Highlands Oncology Group - Fayetteville
 Amanda Nickel Ph: +1 479 872 8130
  Email: anickel@hogonc.com
 Joseph Thaddeus BeckPrincipal Investigator
California
  Greenbrae
 California Cancer Care, Incorporated - Greenbrae
 Jaime Chang Ph: 415-925-5040
  Email: jchang@marinspecialtycare.com
 Peter EisenbergPrincipal Investigator
  Loma Linda
 Loma Linda University Dept.ofLomaLindaCancerCent(3)
 Lorena J Garcia Ph: +1 909 558 3377 33377
  Email: lcgarcia@llu.edu
 Gayathri NagarajPrincipal Investigator
Colorado
  Greenwood Village
 Rocky Mountain Cancer Centers - Greenwood Village
 Cody Culver Ph: 303-321-0302
  Email: cody.culver@usoncology.com
 Mihaela MateiPrincipal Investigator
Florida
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Renita Laureano Ph: 813-745-8314
  Email: renita.laureano@moffitt.org
 Hyo HanPrincipal Investigator
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Lauren White Ph: 404-778-4907
  Email: lauren.white2@emory.edu
 Sujatha M. MuraliPrincipal Investigator
  Marietta
 Northwest Georgia Oncology Centers, PC - Marietta Center
 Kristine Parker Ph: 770-281-5100
  Email: kparker@ngoc.com
 Raul OyolaPrincipal Investigator
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Elizabeth Fors Ph: 913-945-5792
  Email: efors@kumc.edu
 Qamar J. KhanPrincipal Investigator
Kentucky
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Lauren Zutt Ph: 502-629-3456
  Email: lauren.zutt@nortonhealthcare.org
 Janell SeegerPrincipal Investigator
Missouri
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Natalie Bazzell Ph: 314-362-7249
  Email: nbazzell@dom.wustl.edu
 Foluso O. AdemuyiwaPrincipal Investigator
Nebraska
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Bryan Ludwig Ph: 402-559-8874
  Email: bmludwig@unmc.edu
 Elizabeth C. ReedPrincipal Investigator
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Priscilla Garcia
  Email: prgarcia@salud.unm.edu
 Melanie RoycePrincipal Investigator
New York
  Troy
 New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
 Lisa Forbes Ph: 518-489-4030
  Email: lisa.forbes@usoncology.com
 Karen TedescoPrincipal Investigator
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Desy Vounousakis Ph: 614-366-5844
  Email: desy.vounousakis@osumc.edu
 Maryam B LustbergPrincipal Investigator
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Erin Leslie Broadhurst Ph: +1 405 271 8777
  Email: erin-broadhurst@ouhsc.edu
 Waheeha RazaqPrincipal Investigator
Oregon
  Portland
 Northwest Cancer Specialists Vancouver Loc
 Rachel Sautter Ph: 360-573-1061
  Email: rachel.sautter@usoncology.com
 John W SmithPrincipal Investigator
Texas
  Dallas
 Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
 Taqi Mohammad Ph: 214-370-1279
  Email: taqi.mohammad@mckesson.com
 Cynthia OsbornePrincipal Investigator
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Macey Alexander Ph: 214-648-4981
  Email: macey.alexander@utsouthwestern.edu
 Barbara HaleyPrincipal Investigator
Virginia
  Reston
 Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA
 Robyn Mayhew Ph: 703-207-0733
  Email: robynbryant@nvoncology.com
 Mary WilkinsonPrincipal Investigator
Australia
  Perth
 Novartis Investigative Site
New South Wales
  Sydney
 Novartis Investigative Site
Victoria
  Geelong
 Novartis Investigative Site
  Parkville
 Novartis Investigative Site
Austria
  Vienna
 Novartis Investigative Site
  Wien
 Novartis Investigative Site
Belgium
  Charleroi
 Novartis Investigative Site
  Gent
 Novartis Investigative Site
  Liege
 Novartis Investigative Site
  Liège
 Novartis Investigative Site
  Ottignies
 Novartis Investigative Site
  Sint-Niklaas
 Novartis Investigative Site
  Wilrijk
 Novartis Investigative Site
Brazil
  Fortaleza
 Novartis Investigative Site
Sao Paulo
  São Paulo
 Novartis Investigative Site
Czech Republic
  Brno
 Novartis Investigative Site
  Olomouc
 Novartis Investigative Site
  Praha 2
 Novartis Investigative Site
France
  Angers Cedex 9
 Novartis Investigative Site
  Bordeaux
 Novartis Investigative Site
  Creteil
 Novartis Investigative Site
  La Roche sur Yon cedex 9
 Novartis Investigative Site
  Le Mans Cedex
 Novartis Investigative Site
  Marseille
 Novartis Investigative Site
  Nice Cedex 2
 Novartis Investigative Site
  Saint Herblain cedex
 Novartis Investigative Site
  Toulouse Cedex 3
 Novartis Investigative Site
  Villejuif Cedex
 Novartis Investigative Site
Hong Kong
  Hong Kong SAR
 Novartis Investigative Site
Hungary
  Budapest
 Novartis Investigative Site
  Debrecen
 Novartis Investigative Site
  Szolnok
 Novartis Investigative Site
Israel
  Ramat Gan
 Novartis Investigative Site
  Tel-Aviv
 Novartis Investigative Site
Italy
  Cona
 Novartis Investigative Site
  Genova
 Novartis Investigative Site
  Messina
 Novartis Investigative Site
  Milano
 Novartis Investigative Site
  Monza
 Novartis Investigative Site
Japan
  Koto
 Novartis Investigative Site
Netherlands
  Breda
 Novartis Investigative Site
  Rotterdam
 Novartis Investigative Site
Republic of Korea
  Seoul
 Novartis Investigative Site
Republic of Singapore
  Singapore
 Novartis Investigative Site
Russia
  St. Petersburg
 Novartis Investigative Site
  St.- Petersburg
 Novartis Investigative Site
Spain
  A Coruna
 Novartis Investigative Site
  Barcelona
 Novartis Investigative Site
  Cordoba
 Novartis Investigative Site
  La Laguna
 Novartis Investigative Site
  Madrid
 Novartis Investigative Site
  Malaga
 Novartis Investigative Site
  Sevilla
 Novartis Investigative Site
  Valencia
 Novartis Investigative Site
  Zaragoza
 Novartis Investigative Site
Taiwan
  Kuei-Shan Chiang
 Novartis Investigative Site
  New Taipei City
 Novartis Investigative Site
  Taipei
 Novartis Investigative Site
United Kingdom
  Glasgow - Scotland
 Novartis Investigative Site
  London
 Novartis Investigative Site
  Maidstone
 Novartis Investigative Site
  Wirral
 Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01572727
ClinicalTrials.gov processed this data on March 04, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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